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FDA’s partnership approach to tackling health disparity

Aug 7, 2018

Ensuring minorities are represented in clinical trials and sharing culturally sensitive health messaging are two of the ways the U.S. Food and Drug Administration (FDA) is tackling health disparity.

The agency used the recent National Minority Health Month to talk about the importance of achieving health equity and highlight the work it is doing to tackle the problem.

“We strive for the attainment of the highest level of health for all people by enlisting a range of approaches to remove the social and economic obstacles to health faced by racial and ethnic groups,” said Captain Ricardae Araojo, the FDA’s Associate Commissioner for Minority Health and Director of the agency’s Office of Minority Health (OMH).

Outlining ways in which her team is working to tackle health disparity, Capt. Araojo said cross-agency efforts were the best way to protect, promote and advance the public health of some of the country’s most vulnerable and unrepresented groups.

“To better understand these disparities, OMH is supporting a study to assess the impact of advertising and promotional labeling as it relates to vaccine health disparities.”

The OMH has message-tested FDA’s communications with consumer panels and is using the information garnered to shape future health education materials and outreach in minority communities.

It is also working to conduct and fund research on diseases that disproportionally affect minorities, such as HIV/AIDS, diabetes and heart disease, as well as training principle investigators and pharmacists from diverse backgrounds.

“Research shows that people want their health professionals to look like them, so a workforce that reflects the demographics of the community it serves is vital,” said Capt. Araojo.

Another focus area is ensuring minorities are represented during clinical trials.

The OMH partners with organizations, including the Veteran Health Administration’s Office of Health Equity, to encourage more people from diverse backgrounds to volunteer. Two veterans have given up their time to create videos and podcasts on health equity during which they share their own experiences of clinical trials and encourage others to get involved.

“Ensuring minority representation in clinical trials is crucial to improving minority health because we need to understand how different racial and ethnic groups respond to medical products before they are approved for use in the broad population,” said Capt. Araojo.

“The FDA has developed guidance for industry and staff. It provides recommendations on using a standardized approach for collecting and reporting race and ethnicity data used to support marketing applications for FDA-regulated medical products.”

Other recent collaborations include a memorandum of understanding with Yale University.

“Under this agreement, we’ll be working to advance scientific collaborations, outreach, and educational initiatives. Especially exciting is the cultural ambassador’s program, which will engage community members to get more involved in clinical research.

“To create a world where health equity is a reality for all we must involve all stakeholders in new ways of thinking and working. And that requires teamwork, partnerships, and collaboration across disciplines, experiences, and sectors,” Capt. Araojo concluded.

Astellas Patient Advocacy is a function within Corporate Affairs at Astellas that focuses on creating, building and maintaining third-party relationships. We serve as a conduit between Astellas and external stakeholders to help improve patient outcomes, improve access issues and address patients’ unmet needs head on.